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Completed

NCT Number: NCT06395077

Diagnostic Efficiency of Low-dose Cone-beam Computed Tomography in Post-graft Evaluation.

Evaluation of a Low-dose exposure CBCT protocol for post-graft evaluation of treatment of cleft patients

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Key information

Conditions

Alveolar Cleft

Age range

7 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Kristina Hellen-Halme

Malmö, 20250, Sweden

About this study

The patient underwent two CBCT examinations (Accuitomo 170; J Morita Corp., Kyoto, Japan): one examination followed the clinical standard-dose protocol (exposure settings: 90 kV, 5 mA, and 9.4 s), and one, the low-dose protocol (90 kV, 2 mA, 9.4 s). The field of view (FOV) was 6.0 cm x 6.0 cm, the rotation mode was 180 degrees, and voxel size was 0.125 mm. Volume was reconstructed in slices of 1-mm thickness and interval. The dose area products (DAP) were 423 mGy cm2 for the clinical, standard-dose protocol and 172 mGy cm2 for the low-dose protocol.

The aim was to establish if a low-dose protocol could provide diagnostically acceptable image quality for assessing bone healing after alveolar bone grafting.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with oral facial clefts who had undergone alveoalar bone grafting. Healing control after 6 months.

Exclusion criteria

-

Treatment and study plan

CBCT low-dose protocol

Diagnostic Test

The patient underwent two CBCT examinations (Accuitomo 170; J Morita Corp., Kyoto, Japan): one examination followed the clinical standard-dose protocol (exposure settings: 90 kV, 5 mA, and 9.4 s), and one, the low-dose protocol (90 kV, 2 mA, 9.4 s).

Primary outcomes

  1. Evaluation of post grafting in patients with clefts.

    Time frame: 2 years

    CBCT investigation after surgery of patients with alveolar clefts.

Sponsors and collaborators

Lead sponsor

Malmö University

Other

Collaborators

  • Region Skane

Registry information

Official study title

Diagnostic Efficiency of Low-dose Cone-beam Computed Tomography in Post-graft Evaluation of Swedish Paediatric Patients With Alveolar Clefts

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
May 1, 2024
Registry last updated
May 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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